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Approved Risk Evaluation and Mitigation Strategies (REMS)


Shared System REMS
REMS last update:

What is the purpose of the REMS?

What do participants need to know?

Assessment Plan

This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
05/30/2019
05/11/2015 Modified to add the risk of major adverse cardiovascular events associated with testosterone replacement therapy to the Medication Guide.
11/12/2014 Modified to add a new application site diagram in the Medication Guide.
06/19/2014 Modified to add the risk of venous thromboembolic events associated with testosterone use to the Medication Guide.
05/20/2013 Modified to add the new applicant name, address, and contact information to the Medication Guide.
09/20/2012 Modified to add information that is consistent with labeling provided for AndroGel® (testosterone gel) 1.62% in the Medication Guide.
11/30/2011 Modified to add information about the risk of secondary exposure in children in the Medicaiton Guide.
03/10/2011 Modified to

  1. make revisions to the Medication Guide including the updates to the Medication Guide text described above [in the approval letter]
  2. replace Solvay Pharmaceuticals, Inc with the name and address of Abbott Products, Inc.
09/18/2009 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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